HealthyPhase 1NCT05183360
A Study in Healthy Japanese and Chinese Men to Test How Well Different Doses of BI 706321 Are Tolerated
A Phase 1 study testing BI 706321 in people with Healthy, run by Boehringer Ingelheim at 1 site in Japan.
Trial summary
Part I: The main objectives of this trial are to investigate safety, tolerability, and pharmacokinetics (PK) of BI 706321 in healthy Japanese male subjects following oral administration of multiple rising doses. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men only
- Conditions the study is for
- Healthy
- What is being tested?
- BI 706321
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteJapan
- Study dates
- 7 Feb 2022to 8 Aug 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure [BP], pulse rate (PR) including body temperature, 12-lead electrocardiogram (ECG), and clinical laboratory tests at screening visit
- Part I: Japanese ethnicity, according to the following criteria:
- -- born in Japan, have lived outside of Japan <10 years
- Part II: Chinese ethnicity including Taiwanese, according to the following criteria:
- -- have parents and grandparents who are Chinese
- Age of 20 to 45 years (inclusive) at screening visit
Show all 12Show fewer
- Body mass index (BMI) of 18.5 to 25.0kg/m2 (inclusive) at screening visit
- Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation
- Willingness to comply with contraception requirements. Subjects who are sexually active must use adequate contraception methods throughout the trial and until three months after the last administration of trial medication. Adequate methods are:
- A vasectomy performed at least 1 year prior to screening and with medical assessment of the surgical success or
- Surgical sterilization, including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy, of the subject's female partner or
- The use of condoms, if the female partner uses an adequate contraception method in addition, e.g., intrauterine device (IUD), or hormonal contraception, such as implants and injectables, combined with oral or vaginal contraceptives, that started at least 2 months prior to first drug administration, or barrier method, e.g., diaphragm with spermicide
Who cannot join
- Any finding in the medical examination (including BP, PR, body temperature or ECG) deviating from normal and assessed as clinically relevant by the investigator at screening visit
- Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 40 to 90 mmHg, or pulse rate outside the range of 40 to 99 bpm at screening visit
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance at screening visit
- Any evidence of a concomitant disease assessed as clinically relevant by the investigator
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
Show all 9Show fewer
- Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders, per investigator judgement
- History of relevant orthostatic hypotension, fainting spells, or blackouts
- Further exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Dose and Multiple Rising Oral Doses of BI 706321 in Healthy Japanese Male Subjects and Single Oral Dose of BI 706321 in Healthy Chinese Male Subjects (Double-blind, Randomised, Placebo-controlled, Parallel Group Design)
Part I: The main objectives of this trial are to investigate safety, tolerability, and pharmacokinetics (PK) of BI 706321 in healthy Japanese male subjects following oral administration of multiple rising doses.
Part II: The main objectives of this trial are to investigate safety, tolerability, and pharmacokinetics (PK) of BI 706321 in healthy Chinese male subjects following oral administration of single dose.
- Conditions
- Healthy
- Being tested
- BI 706321, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 706321Drug
BI 706321, tablet, oral use
PlaceboDrug
Placebo, tablet, oral use
| Study group | Role | What they receive |
|---|---|---|
| Placebo Matching BI 706321 (Part I) | Placebo comparator | This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of placebo tablets matching BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of placebo tablets matching BI 706321. Receives: Drug: Placebo |
| 2 mg BI 706321 (Part I) | Experimental | This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of one 2 milligrams (mg) tablet BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of one 2 mg tablet BI 706321. Receives: Drug: BI 706321 |
| 5 mg BI 706321 (Part I) | Experimental | This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of one 5 mg tablet BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of one 5 mg tablet BI 706321. Receives: Drug: BI 706321 |
| 8 mg BI 706321 (Part I) | Experimental | This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of three tablets totaling 8 mg of BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of three tablets totaling 8 mg of BI 706321. Receives: Drug: BI 706321 |
| 10 mg BI 706321 (Part I) | Experimental | This trial consisted of two parts: a single-dose part and a multiple-dose part.
Single-Dose Part:
On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of two tablets totaling 10 mg of BI 706321.
Multiple-Dose Part:
From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of two tablets totaling 10 mg of BI 706321. Receives: Drug: BI 706321 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Drug-related Adverse Events
The percentage of participants treated with investigational drug who experience such an event.
Percentage of participants with treatment-emergent adverse events assessed as drug-related by the investigator are reported.
Percentages are calculated using total number of participants per treatment as the denominator.
Measured: From 1st drug administration on Day 1 till Day 19 + 16 days Residual Effect Period (REP), up to 35 days.
Secondary outcomes (8)
Single-Dose Part: Area Under the Concentration-time Curve of the BI 706321 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUCR0-∞)
The area under the concentration-time curve of the BI 706321 in plasma over the time interval from 0 extrapolated to infinity (AUCR0-∞) after the first dose administration is reported.
Measured: Within 3 hours prior to administration and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours, and 1.5, 2, 3, and 4 days after first BI 706321 administration.
Single-Dose Part: Maximum Measured Concentration of BI 706321 in Plasma (Cmax)
The maximum measured concentration of BI 706321 in plasma (Cmax) after the first dose administration is reported.
Measured: Within 3 hours prior to administration and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours, and 1.5, 2, 3, and 4 days after first BI 706321 administration.
Single-Dose Part: Time From Dosing to Maximum Measured Concentration of BI 706321 in Plasma
The time from dosing to maximum measured concentration of BI 706321 in plasma after first drug administration is reported.
Measured: Within 3 hours prior to administration and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours, and 1.5, 2, 3, and 4 days after first BI 706321 administration.
Area Under the Concentration-time Curve of BI 706321 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss)
Area under the concentration-time curve of BI 706321 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) after single and multiple dose administration is reported.
Measured: Within 3 hours prior to administration and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours, and 1.5, 2, 3, and 4 days, and additional time points up to 26 days after first BI 706321 administration.
Maximum Measured Concentration of BI 706321 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss)
Maximum measured concentration of BI 706321 in plasma at steady state over a uniform dosing interval τ (Cmax,ss) after single and multiple dose administration is reported
Measured: Within 3 hours prior to administration and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours, and 1.5, 2, 3, and 4 days, and additional time points up to 26 days after first BI 706321 administration.
Minimum Concentration of BI 706321 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmin,ss)
Minimum concentration of BI 706321 in plasma at steady state over a uniform dosing interval τ (Cmin,ss) after single and multiple dose administration is reported.
Measured: Within 3 hours prior to administration and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours, and 1.5, 2, 3, and 4 days, and additional time points up to 26 days after first BI 706321 administration.
Accumulation Ratio Based on Cₘₐₓ (Rᴀ,ᴄₘₐₓ,ₛₛ)
The accumulation ratio based on Cₘₐₓ (Rᴀ,ᴄₘₐₓ,ₛₛ) shows how much the drug concentration increases at steady state compared to the first dose. It is calculated as a ratio of Cₘₐₓ at steady state (Cₘₐₓ,ₛₛ) and Cₘₐₓ after the first dose (Cₘₐₓ).
Rᴀ,ᴄₘₐₓ,ₛₛ = Cₘₐₓₛₛ/Cₘₐₓ.
Measured: Within 3 hours prior to administration and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours, and 1.5, 2, 3, and 4 days, and additional time points up to 26 days after first BI 706321 administration.
Accumulation Ratio Based on AUC₀-ₜ (Rᴀ,ᴀᴜᴄ₀-ₜ,ₛₛ)
The accumulation ratio based on AUC₀-ₜ (Rᴀ,ᴀᴜᴄ₀-ₜ,ₛₛ) shows how much the total drug exposure over a uniform dosing interval τ increases at steady state compared to the first dose. It is calculated as a ration of AUC₀-ₜ at steady state (AUC₀-ₜₛₛ) and AUC₀-ₜ after the first dose (AUC₀-ₜ).
Rᴀ,ᴀᴜᴄ₀-ₜ,ₛₛ = AUC₀-ₜₛₛ/AUC₀-ₜ.
Measured: Within 3 hours prior to administration and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours, and 1.5, 2, 3, and 4 days, and additional time points up to 26 days after first BI 706321 administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start7 Feb 2022
- Primary completion12 Aug 2022
- Study completion8 Aug 2024
Why it stopped: Company decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05183360
- Sponsor's protocol ID
- 1425-0008
- Status last verified
- Sep 2025
- First submitted
- 20 Dec 2021
- Last updated
- 23 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datasharing
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Dose and Multiple Rising Oral Doses of BI 706321 in Healthy Japanese Male Subjects and Single Oral Dose of BI 706321 in Healthy Chinese Male Subjects (Double-blind, Randomised, Placebo-controlled, Parallel Group Design)
- ClinicalTrials.gov ID
- NCT05183360
- Acronym / sponsor ID
- 1425-0008
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company decision
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 12 Aug 2022 (actual)
- Study completion
- 8 Aug 2024 (actual)
- First posted
- 10 Jan 2022 (actual)
- Results
- Posted 23 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Part I: The main objectives of this trial are to investigate safety, tolerability, and pharmacokinetics (PK) of BI 706321 in healthy Japanese male subjects following oral administration of multiple rising doses.
Part II: The main objectives of this trial are to investigate safety, tolerability, and pharmacokinetics (PK) of BI 706321 in healthy Chinese male subjects following oral administration of single dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo Matching BI 706321 (Part I) | Placebo comparator | Drug: PlaceboThis trial consisted of two parts: a single-dose part and a multiple-dose part. Single-Dose Part: On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of placebo tablets matching BI 706321. Multiple-Dose Part: From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of placebo tablets matching BI 706321. |
| 2 mg BI 706321 (Part I) | Experimental | Drug: BI 706321This trial consisted of two parts: a single-dose part and a multiple-dose part. Single-Dose Part: On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of one 2 milligrams (mg) tablet BI 706321. Multiple-Dose Part: From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of one 2 mg tablet BI 706321. |
| 5 mg BI 706321 (Part I) | Experimental | Drug: BI 706321This trial consisted of two parts: a single-dose part and a multiple-dose part. Single-Dose Part: On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of one 5 mg tablet BI 706321. Multiple-Dose Part: From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of one 5 mg tablet BI 706321. |
| 8 mg BI 706321 (Part I) | Experimental | Drug: BI 706321This trial consisted of two parts: a single-dose part and a multiple-dose part. Single-Dose Part: On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of three tablets totaling 8 mg of BI 706321. Multiple-Dose Part: From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of three tablets totaling 8 mg of BI 706321. |
| 10 mg BI 706321 (Part I) | Experimental | Drug: BI 706321This trial consisted of two parts: a single-dose part and a multiple-dose part. Single-Dose Part: On Day 1, after fasting for at least 10 hours overnight, participants received a single dose of two tablets totaling 10 mg of BI 706321. Multiple-Dose Part: From Day 6 to Day 19, after fasting for at least 10 hours overnight, participants received a daily dose of two tablets totaling 10 mg of BI 706321. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure [BP], pulse rate (PR) including body temperature, 12-lead electrocardiogram (ECG), and clinical laboratory tests at screening visit
- Part I: Japanese ethnicity, according to the following criteria:
- -- born in Japan, have lived outside of Japan <10 years
- Part II: Chinese ethnicity including Taiwanese, according to the following criteria:
- -- have parents and grandparents who are Chinese
Key exclusion criteria (9 listed)
- Any finding in the medical examination (including BP, PR, body temperature or ECG) deviating from normal and assessed as clinically relevant by the investigator at screening visit
- Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 40 to 90 mmHg, or pulse rate outside the range of 40 to 99 bpm at screening visit
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance at screening visit
- Any evidence of a concomitant disease assessed as clinically relevant by the investigator
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI 706321BI 706321, tablet, oral use | Drug | 10 mg BI 706321 (Part I), 2 mg BI 706321 (Part I), 5 mg BI 706321 (Part I), 8 mg BI 706321 (Part I) |
| PlaceboPlacebo, tablet, oral use | Drug | Placebo Matching BI 706321 (Part I) |
Primary outcome
Percentage of Participants With Drug-related Adverse Events
Time frame: From 1st drug administration on Day 1 till Day 19 + 16 days Residual Effect Period (REP), up to 35 days.
The percentage of participants treated with investigational drug who experience such an event. Percentage of participants with treatment-emergent adverse events assessed as drug-related by the investigator are reported. Percentages are calculated using total number of participants per treatment as the denominator.
8 secondary outcomes
Single-Dose Part: Area Under the Concentration-time Curve of the BI 706321 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUCR0-∞)
Time frame: Within 3 hours prior to administration and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours, and 1.5, 2, 3, and 4 days after first BI 706321 administration.
Single-Dose Part: Maximum Measured Concentration of BI 706321 in Plasma (Cmax)
Time frame: Within 3 hours prior to administration and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours, and 1.5, 2, 3, and 4 days after first BI 706321 administration.
Single-Dose Part: Time From Dosing to Maximum Measured Concentration of BI 706321 in Plasma
Time frame: Within 3 hours prior to administration and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours, and 1.5, 2, 3, and 4 days after first BI 706321 administration.
Area Under the Concentration-time Curve of BI 706321 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss)
Time frame: Within 3 hours prior to administration and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours, and 1.5, 2, 3, and 4 days, and additional time points up to 26 days after first BI 706321 administration.
Maximum Measured Concentration of BI 706321 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss)
Time frame: Within 3 hours prior to administration and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours, and 1.5, 2, 3, and 4 days, and additional time points up to 26 days after first BI 706321 administration.
Minimum Concentration of BI 706321 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmin,ss)
Time frame: Within 3 hours prior to administration and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours, and 1.5, 2, 3, and 4 days, and additional time points up to 26 days after first BI 706321 administration.
Accumulation Ratio Based on Cₘₐₓ (Rᴀ,ᴄₘₐₓ,ₛₛ)
Time frame: Within 3 hours prior to administration and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours, and 1.5, 2, 3, and 4 days, and additional time points up to 26 days after first BI 706321 administration.
Accumulation Ratio Based on AUC₀-ₜ (Rᴀ,ᴀᴜᴄ₀-ₜ,ₛₛ)
Time frame: Within 3 hours prior to administration and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours, and 1.5, 2, 3, and 4 days, and additional time points up to 26 days after first BI 706321 administration.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datasharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 706321 in people with Healthy, run by Boehringer Ingelheim at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Drug-related Adverse Events (time frame: From 1st drug administration on Day 1 till Day 19 + 16 days Residual Effect Period (REP), up to 35 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025; AzTrials last refreshed its copy on 7 Nov 2026.